V.S.Z Afternoon Conference and Visit to the CSSD Department Study Visit Report
20 June 2002
Virga Jesse Hospital, Hasselt, Belgium
On 20 June 2002 the society
Vereniging Sterilisatie in het Ziekenhuis (VSZ) visited the Virga Jesse Hospital in Hasselt. The hospital has about 600 beds of which 160 are surgical. The main activities focus on orthopedic, cardiac, neuro and vascular surgery.
In his introduction our chairman Wim Renders sketched the slowly evolving evolutions within our domain of expertise. Quality management has found its way into the CSA. Most departments are planning or carrying out architectonic and organisational improvements. The training of sterilisation assistants and managers too is thoroughly revised and adapted. The next training course for assistants starts on 26 September in the Katho in Roeselare.
Our chairman pointed to the necessity of there being written procedures in the CSA. The ministry is increasingly checking whether this is the case. The quality handbook has to be the repository of the credentials of the central sterilisation department and has to form the basis of a well structured department.
After this introduction we were welcomed by the people in charge of the CSA of Virga Jesse Hasselt: Armand Busselen and Inge Cleeren. The evolution and the eventual establishment of the CSA in Virga Jesse were discussed. The software management package (T-doc) was introduced. It was pointed out that the CSA has a very personnel friendly character which is expressed in amongst others the work schedule, the attention for ergonomics, the infrastructure (shower, airconditioning, ...)
Then mr. Heinze Sikkema, head of the CSA of the medical centre Noorderbreedte in Leeuwarden talked about the steps approach one has to apply when setting up a new or reorganised CSA. This requires careful and systematic planning.
Apart from determining the present position (where are we and what are our objectives) which involves an evaluation of working methods, distribution, production, bottlenecks etc. in a first orientation phase the main lines have to be drawn.
Important are the latest developments in the sterilisation area, new wishes of the personnel and of the customers of the CSA, visits to colleagues and to their departments.
This is followed by the preparatory phase. A project team which consists amongst others of the purchasing, technical and informatics departments, CSA personnel, pharmacy. Quotations are requested and discussed, capacity calculations made, logistics and routing analysed, ergonomics and space requirements are calculated, equipment compared etc. During the decision making process this multitude of facets finds a definite place within the whole.
This talk illustrated that renovation within the CSA is something which has to be done after careful preparation and in consultation with different departments. Speed will never have the desired endresult. When one neglects through haste certain important aspects this will have detrimental consequences for the organisation. Moreover it will be extremely difficult to correct the mistakes afterwards, just think of architectural designs. Think before starting should be the watchword.
The last talk was given by Patrick Cornelissen staff member of medical-technical services of the Jan Portael hospital in Vilvoorde. He talked in depth about the disinfecting and sterilising of critical medical materials. The long used classification into low and high level disinfecting still exists but is not specific enough anymore e.g. an endoscope and a vaginal speculum both need a high level of disinfection but a thorough disinfection of an endoscope is much more difficult than of a speculum. Re-usables are not necessarily easier to clean: laparoscopic tongs of an older generation which cannot be disassembled, Kerrisons...
The creation of subgroups with their own specific points of attention is called for. With his long experience as head of the CSA he once more pointed out that cleaning is the most important step in the disinfection and sterilisation process. It is a pre-condition for an adequate follow-up procedure. But it is also the first phase in which corners are cut when the CSA comes under time pressure.
Finally he sketched a slightly pessimistic vision of the future. There is a growing discrepancy between the cost price of the materials used during operations and the related revenues for the hospital. It is unfortunate when in times of cost controls savings have to be made in cost centres which should in actual fact be upgraded. The minimal procedures which sometimes have to be followed for medical devices do not allow any further cost cutting. There is no step back beyond 'rudimentary'.
This study day was a very successful one. Our thanks go to the organisers who once again have given the participants a lot of food for thought.
Ludwig Van de Voorde
Head of CSSD
AZ Maria Middelares
Sint Niklaas
For once, Friday the 13th was a lucky date because in September it marked the first day of the
EFHSS Conference, which this year was held jointly with the conference of the
Irish Association of Sterile Services Managers (IASSM) in Dublin.
In her opening speech, Oonagh Ryan, chairman of the
IASSM, was able to welcome more than 300 delegates from 24 - not only European - countries.
Tim Galekop from Belgium gave the first talk on "Practical aspects of packaging". This was also dedicated to the memory of Jack van Asten who died last spring. Galekop recalled a few episodes from Jack’s life and elaborated on a number of topics for which he had conducted important research and development tasks.
Galekop went on to say that packing materials should be non-linting. He then highlighted some of the key developments in this domain, ranging from the 1930s when textile packing materials had been introduced through the 1960s, which saw the advent of heat-sealable packing materials, to the introduction of nonwoven materials in the 70s. Galekop stated his own preference for double packaging, stating that the different folding of both layers was better able to prevent microbial migration through the fabric than two-layered material, in which the folds were formed at the same locations. In respect of patient safety, this was an important factor in reducing the infection rate. Disposable materials were not more expensive and contributed further to reducing the infection rate.
Eoin Flavin, Ireland, outlined developments in his company, Steri Tex, which supplies OR departments with ready-to-use sets composed of reusable materials. The company had grown from a laundry contractor to become a specialist supplier. Flavin summarised the properties which the reusable materials must posses, such as e.g. a weaving density of 6000 threads/inch. On the basis of studies conducted in cooperation with OR personnel, the sets and procedures had been increasingly standardised - an important quality assurance measure. Furthermore, the assignment of a barcode to each set ensured complete tracking.
Joost van Doornmalen, Netherlands spoke on "Validation and routine checks in the practical setting". He began by defining the terms "clean" and "sterile", while pointing to the problems associated with such definitions. He described the routine checks to be conducted as well as the technical aspects of measurement and calibration. He drew attention to the fact that the measured values obtained in the course of routine checks served as proof of quality, but were not a substitute for validation. He then went on to elaborate in detail on steam penetration in open and closed lumened instruments and described the helix test as a test example for a lumened instrument; but findings for this test procedure had been available only for the past five years.
René Vis, Netherlands, in the afternoon described his experiences with loaned instruments. First, he outlined the basic problems, e.g. on using loaned instruments one often found oneself confronted with an unfamiliar device, for which no processing information was available either. Nor were the containers often suitable for processing. Vis then highlighted the responsibilities of all parties involved. Accordingly, the loaner was responsible for the instruments and associated information, but the hospital was responsible for decontamination, and had to issue a certificate to that effect. When using unfamiliar instruments, Vis recommended that a two-day run-in period be planned. The safest approach was also to always view instruments as non-clean, even if they had already been sterilised by the loaner these should be processed again in all cases because the hospital was ultimately responsible here.
[ Slide Show / Presentation ]
Peter Newson, England, spoke about "Validation of indicators". First of all, he outlined the fundamentals of the Bowie & Dick test and pointed out that it was very difficult to detect air in an empty steriliser. Prefabricated Bowie & Dick test packs had always to be compared with the original 7kg laundry pack. Newson stated that here standardisation had its limitations, e.g. there was no higher-level control body, but rather the manufacturers themselves conducted certification. To be on the safe side, he recommended that the test packs employed be certified again by an independent body and he then called upon users to take a demanding stance vis-à-vis the manufacturers, and always insist on getting the pertinent documentation for devices.
The last talk of the first day was given by Tony Kerry, England, on the subject of auditing. He stated that, in addition to the OR, the sterile supply department was the most material-intensive department in the hospital, and went on to outline some of the problems encountered. For example, often there was too little control. Too little attention was paid to staff management and training. Moreover, equipment was often old and poorly maintained.
Kerry stressed that an audit did not take place in the office but rather that the auditor had to check the prevailing conditions on site. It was advantageous if hygiene specialists, the head of the sterile supply departments and the entire team could be present. He then went on to give a few examples of what in England had led to a "red alert" rebuke. He described the hospital infection rates as unacceptable and made an appeal - especially at a time when financial resources were scarce - that attention be paid to the improvements which were available free of cost. Useful information on this topic could be consulted at
www.medical-devices.gov.uk or at
www.nhsestates.gov.uk.
The very interesting first day of the conference was rounded off with an equally interesting evening event during which the very load singing made some of the delegates hoarse; but this hardly prevented anyone from appearing on time at the lectures next morning.
Wim Renders opened the second day with a few words of thanks to the exhibitors who had made it possible to hold the conference and he then drew attention to the
EFHSS website
www.efhss.com, which features some interesting novelties.
Gerard Colleran, Ireland, in his talk on biodecontamination gave a figure of 5000 deaths each year due to nosocomial infections. This gave rise to costs to the tune of more than 1 billion British pounds per year. Therefore liability issues were of enormous importance. Colleran summarised some essential points that could contribute to preventing infection. He evoked the old strategies already established by Pasteur and stated that the latter’s experiments showed that microbes adhered to particles - this was of paramount importance in infection prevention. Colleran also called to mind that residues on instruments had consequences even if they were not composed of viable microorganisms; likewise, biological residues could by all means replicate. Disinfectants were neutralised to an extent by soils, with the latter affording protection to microbes. Therefore cleaning was the most important single step in processing.
Toni Zanette, Germany, gave a talk about Instrument Tracking. He emphasised the need, not least for reasons dictated by liability legislation, to collect, archive and keep ready for access large quantities of data in the CSSD. Therefore, complete computerisation of all activities had become almost indispensable in the present day. Zanette presented a system that operates with a computerised matrix code and which had been tested, among others, at Tübingen University Hospital. The code is engraved on each instrument and is rendered machine-readable by means of a camera. This thus provides for complete tracking. In turn, this means that an ongoing inventory can be made, which ensures better utilisation of the available instruments and could thus ultimately contribute to cost reductions. During the ensuing discussion, someone asked whether the computerised workstations might not pose a safety risk as far as cleanliness was concerned. Zanette replied that flat screens and disinfectable keyboards, as used in the industrial setting, were suitable.
Under the heading "There’s something in the air", Ronnie Russell went on show what is not visible but is nonetheless present. He, too, briefly spoke about the experiments by Pasteur and Tyndall, and explained what are known as 'bioaerosols' comprising microorganisms, their constituents, and possibly metabolite products, which often adhere to particles. There are certain air currents and in particular turbulences that could contribute to microbial dissemination. Russell demonstrated a few sampling techniques that took account of the spread and deposition patterns of such aerosols. He showed how strong turbulences could be caused for example by persons in a working area, which is why access to critical areas should be kept to a minimum, especially where personnel from other departments were concerned.
Peter Hooper, England, outlined the requirements of the British Health Technical Memorandum HTM 20/30 for washer-disinfectors, while portraying its history and comparing it with the European prEN ISO 15883.
A standardised approach was taken for all instruments - however, there was now the problem of CJD. CJD, to cite Hooper, was not a newly emerged problem because there had always been sporadic cases of disease even before the advent of vCJD. The use of single-use instruments in all areas, which would certainly solve the problem, was doomed to failure, alone because of the costs involved. During processing, sterilisation had its technical limitations because for example the temperature could not be indefinitely increased in a steriliser, which is of course a pressurised container. Hence cleaning in the washer-disinfectors was all the more important, stated Hooper, because what was involved were proteins, and protein removal was also a standard requirement. But in this respect the washer-disinfectors should have certain features. For instance, provision should be made for complete empting and self-cleaning of these machines. Special importance should also be ascribed to checking for protein residues after cleaning.
The second day of the congress ended with a few short lectures. Sheila Sheahan and Patricia Doheny, engaged in training at the Institute of Technology in Tallaght, spoke about validation and quality management as per ISO 9001. Philip de Vries, Netherlands, explained the functional method of the Electronic Test Systems (ETS, manufactured by 3M).
In her closing remarks, Oonagh Ryan thanked all members of the organisational committee and from industry. And like many congresses before, this one had one shortcoming: it was over too quickly. The delegates would certainly have liked to have had more time to engage in discussion with colleagues and, of course, to visit the lovely city of Dublin. The latter will have to wait until a holiday in Ireland sometime; but there will be an opportunity for the former next year in July at the
EFHSS Congress in Winterthur.
In keeping with tradition the members of the German Society for Sterile Supply
(DGSV) met once again for their annual conference in early October. Likewise, in keeping with tradition they met this year again in Potsdam. More than 200 delegates had travelled on this occasion to the Seminaris Seehotel - an expression of the widespread interest in the principle topic of this year’s congress: Quality Management (QM).
The members’ general meeting held at the beginning of the conference had some successes to announce, such as for example a further growth in membership, successful cash-keeping over the past year and progress in efforts to have advanced training recognised; it also had some novelties: the
DGSV chairman, Toni Zanette, announced his resignation as had already been indicated. But this does not mean that he will be completely withdrawing from the society’s activities; he will be relieved of some tasks and will thus have more time to devote to private interests. Anke Carter has been appointed chairman and Josef Graf vice chairman on a temporary basis. New elections for the board of directors will take place on schedule in 2004.
The conference was opened on 3 October with a speech by Dr. Kaiser, Medical Officer of the Potsdam Public Health Office. She highlighted the already noticeable successes scored in quality management. For example, advertisements for vacant positions in the field of sterile supply now in principle state the specialist qualifications required - something for which not least the
DGSV has to be thanked.
Dr. Zastrow, Coordinator for Guidelines and Public Relations of the German Society for Hospital Hygiene (DGKH) reported how only a few years ago proposals to introduce specialist courses for sterile supply personnel were rejected, for example by the German Hospital Association, as being superfluous. In the meantime, both EN ISO 9001 and the RKI guideline on processing call for personnel training; indeed, explicit reference is made to the
DGSV training regulations. Well-trained personnel, to cite Zastrow, are a guarantor of superb quality.
Dr. Schmidt from Brandenburg State Medical Council, who is also a member of the Medical Quality Assurance Working Group, conceded that knowledge of sterile supply was poor among doctors. This made it all the more important to strengthen the link between the sterile supply department and the users of the sterile device, in order to foster constructive cooperation.
Even before the actual talks on the agenda for this conference got under way, delegates were invited to next year’s event: Esther Wirth from Switzerland presented the city of Winterthur where next year the congress of the
SGSV) will be held jointly with the
EFHSS congress. This will be held from 3 - 5 July and will have as its topic "Processes". Next year the
SGSV will be celebrating the 20th anniversary of its foundation and is hoping for many delegates from other European countries - provision will be made for simultaneous interpretation in English, German and French.
T. Kull, a Swiss attorney, opened the programme with a talk on quality management entitled "Must or Should"? It soon became clear that quality management is naturally a Must, especially because the environment will insist on it in the event of any procedural deviation or indeed of a claim. Kull pointed out that the RKI Guideline also called for quality management, but the choice of system was left to the individual department. It must be ensured that working procedures are conducted in a consistent manner and yield similar, reproducible results. Thus a QM system could ultimately also contribute to cost reductions. But to a large extent, to cite Kull, quality is "produced in the head" - staff motivation is the chief determinant of success.
M. Mielke from the Robert Koch Institute stressed that quality management in the healthcare sector should not mean "management of an inferior quality". Citing by way of example nosocomial infections, he elaborated on the difficulties that could be encountered here. For example, one could deem instrument processing as being qualitatively adequate if the devices did not give rise to nosocomial infections when used. But only a small fraction of the potential pathogens could be detected at all, and this was even more difficult in the case of viruses. Furthermore, long incubation times (in the case of prions 30 - 40 years) often made it impossible to establish a link. Mielke also stressed that personnel training was the most important determinant of quality assurance. In this respect, the activities of the specialist societies were indispensable.
A. Strunk from the German Society for Quality outlined the practical experiences gleaned from the introduction of a quality management system by a dental association and stated that it was possible to reduce costs even in small organisations when using a QM system. He presented different QM systems such as the ISO system which is recognised in 190 countries throughout the world. This had been developed for the industrial sector and can be used in different branches. He went on to describe the self-audit system of the European Foundation for Quality Management (EFQM) as well as the CTQ System (Cooperation for Transparency and Quality in Hospitals), which likewise is based on self-audit and covers the entire hospital. Strunk stated that to implement a QM system a well-understood nomenclature was indispensable so that employees could understand the targets to be reached and could identify with them. To finish off, he outlined the certification process, ranging from the preliminary tasks to the certification audit and the annual supervisory audit.
The talks were followed by animated discussions, raising in particular legal issues as regards implementation of the RKI Guideline: how can one protect oneself if one’s superior insists on processing a device contrary to the stipulations of the guideline? Various models were discussed, without ultimately finding a valid answer; but it became clear that by invoking the guideline and pointing to the operator’s responsibility and liability involved, superiors have often been made to comply with the requirements.
The afternoon was devoted to different workshops running at the same time. Because the workshops were repeated on the next day, delegates were able to attend a further workshop of their choice.
Under the title "Practice-oriented implementation of an internal audit in the CSSD", a questionnaire for an internal audit was compiled with the delegates of Workshop A; this could then be used to verify the various procedural steps in a CSSD.
Workshop B dealt with batch documentation systems and validable packing processes. The KENUS system from the manufacturer Ulrich was presented; the manufacturer hawo outlined the quality requirements for packaging and for sealing.
Workshop C was organised by the DGSV Quality Task Group and outlined possibilities for quality assurance of automated washer-disinfectors. Of prime focus here was the decision tree for classifying medical devices before processing (see also Recommendations by the Quality Task Group, p. 355).
Workshop D dealt with the use of dataloggers for monitoring washer-disinfectors and autoclaves. Workshop E, organised by the manufacturer Weigert, focused on instrument processing in the light of vCJD. And finally, Workshop F concentrated on the information to be provided by the manufacturer as regards reprocessing of resterilisable devices as per DIN EN ISO 17664 and outlined the benefits offered by such a standard to users and manufacturers; the limitations of this standard were also highlighted.
The second day began with a talk by B. Göckel, Alice Hospital Darmstadt, about the introduction of a QM system for certification of a CSSD. He described the Total Quality Management (TQM) concept in which all staff were involved and stressed that expediency of implementation should not be the pursued goal. Rather, priority should be given to ensuring the participation of each and every individual. Staff should be encouraged to find solutions to problems themselves. Staff training should be well planned and tailored to the level of knowledge and needs of each individual. Ultimately, the system would then be implemented by all staff members and the quality manual compiled by all, rather than by a QM officer. Göckel stressed that the introduction of such a system to begin with also engendered anxiety among staff, e.g. because of having individual procedural steps checked; this anxiety should be curtailed from the outset. If mistakes were made, it was important to establish the reasons for them and find ways of eliminating them rather than apportion blame. He stated that the investment needed to implement the system was not very great in some areas, because often working procedures were indeed being conducted in line with the standards, all that was missing was the appropriate documentation. The costs - a sum in the range of some 40,000 - 50,000 Euros was cited - would be offset not least by savings from not having to engage in reworking following complaints.
C. Hugo reported on a training course for quality manager in the healthcare service organised by the Academy for Medical Training in the Rhineland-Palatinate and the German Society for Quality. The training course comprises 6 modules which can be can be taken separately or in any order. It is possible to take examinations to qualify as a quality officer or quality manager in the healthcare service; the final examination is for quality auditor, which is recognised throughout Europe.
J. Wilke gave the final talk on the legal fundamentals of certification and on how the certification process for a CSSD according to the RKI Guideline unfolds. He began by defining the terms "certification body", "notified body" and "conformity assessment procedure", and elaborated in particular on the definition "placement on the market". Processing for a third party did not constitute placement on the market, if items were processed and returned to the same owner. Wilke also stressed that certificates were also awarded for meeting the specifications while assuring uniform quality, something that says nothing about the absolute quality. To finish off, he gave some practical tips for certification, including on the validity of certificates and on contractual links to the certifier.
Following the workshops the delegates assembled in the early evening for a summary of the events of the 2-day congress by Anke Carter and Josef Graf; delegates were also given an opportunity to make proposals and voice criticism. A change was then already made to next year’s congress programme: although the longer talks, which could go into greater detail, and the workshops had proved popular, many delegates regretted that they could participate in only two of the workshops. By restructuring next year’s programme, delegates will be given the opportunity to attend all workshops successively.
As always the congress was brought to a close with an evening event, which unfortunately was poorly attended this year. But at least this meant that those who did attend had the chance to scrutinise the quality of the buffet in a more leisurely manner. This year’s industrial prizes were awarded to Getinge van Dijk (most innovative product), Merz (best presentation) and, as in the past few years, to Rexam/Bömeda for the most original exhibition booth.
Undoubtedly, quality sometimes means that one gets into a quandary when it has to be delivered in the every day working routine. But here in Potsdam this was definitely not the case, rather the lectures and workshops helped to increase the delegates' motivation - and as we have just learnt, this is one of the most important prerequisites for implementation of a QM system.
V.S.Z - 13th Day of Hospital Hygiene 12 December 2002 "A new look at an old topic" Workshop Report
6 December 2002
'Het Pand', Ghent, Belgium
The workshop took place in the beautiful historical surroundings of 'Het Pand' in Ghent. There were 300 participants. Wim Renders, the chairman of the VSZ, not only expressed his thanks to Santa Claus, who had provided a small present, but also the Hospital Hygiene Department of the University Hospital Ghent and more in particular prof. Gerda Verschraeghe for the invitation to jointly organize the workshop.
Wim Renders said that the invitation came as somewhat of a surprise as at first sight it may seem that Central Sterilisation and Hospital Hygiene have very little in common. But closer scrutiny reveals that there is a lot of common ground between the two disciplines. For this reason he had gladly accepted the invitation. He continued:
"The most important link between both disciplines is undoubtedly the concern for the microbial welfare of the patient. But each discipline has its own specificity. I believe that this should be respected because each discipline requires its own expertise. At the same time I am of the opinion that a better synergy can be established in both areas.
Another common element, but a rather negative one, is the continued underestimation of the importance of the preventative role played by both departments. Both the local authorities and the central health administration could do much more despite the fact that in the area of hospital hygiene a substantial effort is undertaken to contain hospital infections and bacterial resistance. The authorities have realised the seriousness of the infection problem and have undertaken to substantially reduce the number of hospital deaths, estimated at 3000 per year in Belgium, due to infection.
Nevertheless, the different supervisors all too often stress the cost of sterilisation and hospital hygiene on the micro-economic level of the hospital. They do not take into account the benefits in terms of:
for hospital hygiene: fewer infectious and other complications;
for sterilisation: less replacement of instruments as a result of better care, less loss, shorter waiting times for the surgical team etc.
Too little value is attached to the preventative role played by both departments and the important macro-economic savings which are made. In the case of Central Sterilisation this is apparent in the fact that no framework of norms has been worked out, neither for the infrastructure nor for the recognition of the professional expertise of the staff. Is this lack of "interest" perhaps also due to the fact that the academic circles in Belgium, in contrast to other countries, have paid very little attention to sterilisation?
Is this the reason why it is so difficult to be valued and consequently to be taken seriously? This remains an unanswered question. Maybe this workshop can set the process of change in motion. Undoubtedly the interesting papers, which will be presented today, will contribute to a new and long overdue appreciation. At least I hope so."
Wim introduced the first speaker, Adrie de Bruijn, senior researcher in the department of Medical Aids of the RIVM. Adrie spoke about the controls on the washing process in the washing and disinfecting machines.
"A number of principles can be applied to evaluate the results of the cleaning procedures of reprocessed medical devices. The method most commonly used is visual check after cleaning. A simple swab method may assist in objectifying of the cleanliness. By combining a protein staining agent and a swab method residues of proteinous nature can easily be discovered at low cost. Solid instruments with easily accessible surfaces are clear candidates for this method. Also hollow instruments with an inner diameter of at least 2 mm can be swabbed.
A basic swab procedure is described in the (draft) ISO standard for washer disinfectors using common low-cost, domestic purpose cotton swabs and ninhydrine solution as the staining agent. However, the procedure described has some disadvantages. The test is rather time consuming and unexpected colouring reactions occur that interfere with the reading of the colour reaction on the swab. In order to overcome these problems the critical parameters were identified, such as the type of material used in the swab, the consistency of the material of the swab, the amount of liquid on the swab, incubation temperature and incubation time. The improved protocol renders the method both sensitive (2.5µg of bovine serum albumin on a glass plate) and reproducible. (Zentral Sterilisation, 4/2001)"
The next speaker was René Vis, an expert in sterile medical devices of the VU Medical Centre in Amsterdam. He dealt with the difficult problem of the quality control during the cleaning and the disinfecting of flexible scopes.
"In order to supply every patient with a safe instrument a controlled and reproducible cleaning and disinfecting process has to be set up. To achieve this a number of conditions have to be met: qualified personnel, standard working procedures; validated processes and machines, controlled maintenance protocols for the washing and disinfecting of machines and a good traceability of the instruments.
The present state of affairs, however, is that a lot is still done by hand. For more reproducibility it is necessary to mechanically process the flexible endoscopes. Supervision of the procedures and the functioning of the machines is also necessary. It all has to be part and parcel of a quality system.
The supplier of the endoscope has the obligation under the MDD, essential requirements 13.6h, to provide the cleaning and disinfecting procedure. Moreover, prEN 17664 is in the pipeline. It tells the supplier which information has to be given in the procedure. In prEN 15883 part 1 the requirements for a disinfecting machine are described and in part 4 the specific requirements for a scope disinfecting machine are set out. In the Netherlands we also apply guideline 21b of the study committee Infection Prevention (http://www.wip.nl).
In the Netherlands this has led to the recommendation of the Inspectorate of the Medical Care Department to appoint "expert scopes" in each hospital. As a direct consequence the expert on sterile medical devices is now also responsible for the quality of the scope disinfectioning in the Vumc.
The conclusion is that the cleaning and disinfecting is a specialised procedure, which has to carried out by specifically trained personnel. A quality system has to be in place and a supervisor has to be appointed to ensure the necessary quality. Processing flexible endoscopes by hand is not reliable and should be replaced by the use of validated cleaning and disinfecting machines."
Prof. Dr. Heinz-Peter Werner, HygCen, Bisschofshofen, discussed the importance of type-test of washer-disinfectors.
"Often no exact definitions are given for type tests or for the different objectives of the acceptance tests conducted for washer-disinfectors. Conductance of a qualified type test is a prerequisite specified by the Medical Devices Act (MDA) prior to putting a washer-disinfector into operation. This test serves as a basis for risk analysis. The washer-disinfector manufacturer is responsible for its characteristic data. But the objectives of the acceptance test are completely different. During this test cleaning and disinfecting are defined in accordance with the specific conditions prevailing at the operator’s premises. Only quantitative test methods are required for both tests, with top priority being accorded to the standardisation and practical relevance of the challenges used. Hence, methods that ultimately yield only Yes/No results, and this often only on the basis of visual inspection, are not suitable for such tests. Challenges must reflect the real-life conditions, so that on this basis optimal cleaning results can be achieved. (Hyg Med 2002; 27 [11]: 459-466)"
Peter Hooper, a consultant from the UK, was the last speaker in the morning session. He gave a talk on 'Inspection of SSD-the English Experience'.
"Since late 1999 the NHS in the UK has been responding to the perceived increase in the risk of re-usable medical devices and the association with vCJD. Whilst a number of documents and initiatives have been introduced the main impetus in raising standards has been via inspections of all SSDs. These started with a small sample of healthcare facilities of all types and sizes. The report for this series of inspections was not published until sometime and it was undertaken by events.
A specific inspection of sites performing neurosurgery and posterior ophthalmic work was undertaken but because of the sensitive nature of this report a new and complete inspection was undertaken in England. If the outcome at any hospital was in doubt a further inspection followed by a detailed action plan was put to the hospital Executive. The severity and importance of these surveys effectively created a raising of standards via publication of survey results.
Hospitals placed business cases for centralised funding and new equipment, instrumentation and building layouts are being introduced. The prioritisation of these funds were checked via a final set of quality control inspections to check that action plans had been put into practice.
All SSDs have become familiar with this pattern of inspection, funding and re-inspection and are aware that there is a continuing need to demonstrate to themselves and their patients that re-usable medical devices are being re-processed in the proper manner."
This paper brought a very stimulating morning session to a close. In the afternoon the focus was on Hospital Hygiene.
The participants appreciated the fact that the borders of their own discipline were crossed. They found this very enriching as it was possible in this way to find out about the state of affairs in another discipline. This will undoubtedly lead to a better understanding and more insight. This experiment should definitely be repeated by for example bringing together surgical nurses, surgeons, endoscopists etc.
